• Regulatory Affairs Specialist

    Requisition ID
    2018-4676
    # of Openings
    1
    Job Location(s)
    North Point Hong Kong
    Travel
    Less than 10%
    Education
    Bachelor's Degree, Master's Degree, Post Grad
    Position Type
    Full Time
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Affairs Specialist is responsible for assisting Regulatory Affairs Manager to coordinate and handle regulatory affairs in Hong Kong and coordinate & manage timely Regulatory Submissions between local company and our own overseas manufacturers.

    Responsibilities

    • Coordinate and Manage timely Regulatory Submissions between local company and our own overseas Manufacturers.
    • Coordinate and implement the registration process for the company products
    • Act as a bridge between the legal bodies and the company.
    • Work with our manufacturers to provide strategy and multiple options for meeting regulatory requirements
    • Personally write and review regulatory submissions as needed
    • Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse)
    • Create training documents to improve regulatory skills in Local office and other manufacturers
    • Train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable
    • Negotiate with local authorities on behalf of Company objectives
    • Support reimbursement efforts for submissions when applicable
    • Represent the company as a member of industry organizations
    • Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements

    Qualifications

    • Degree in Science, Engineering or any other related disciplines
    • 2 years of regulatory working experience in MNC, preferably in medical device or pharmaceutical industry
    • Experience in negotiating with regulatory authorities would be an advantage
    • Excellent organizational and interpersonal skills, positive working attitude and be a good team player.
    • Attend to details and able to work with limit supervision.
    • Able to work with both internal and external customers from different level
    • Fluent in English and Chinese, both written and spoken.

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